CCEDC Ideas x Innovation Network (i2n) works each day to make southeastern PA the best possible place for early-stage and technology-driven companies to start, grow, and thrive. Through the work of the Ideas x Innovation Network, entrepreneurs, innovators, and startups of Chester and Delaware counties gain access to all the resources, knowledge, and funding necessary to become successful, commercially viable enterprises and thereby make a positive impact on society and our regional economy.

PhysisPD Consulting provides executive leadership, advisory, execution and consulting expertise to the program management, advancement, development, manufacturing operations, and commercialization of new technologies, products and services, and M&A due diligence and integration that drives successful business growth in MedTech, Life Sciences or Commercial organizations.

Led the management of the TMC Cardiovascular Interventional Systems Entry Site Management, Lesion Access, and Interventional Solutions product lifecycle portfolios. Managed over 150 associates across various groups, including Product Lifecycle Management (PLCM), Project Management Office (PMO), Applied Technology and Evaluation, Product Development, Process Development, Engineering, and Manufacturing Engineering. Demonstrated organizational innovation, fostering collaboration amongst engineering groups to deliver globally compliant new product and process solutions, as well as manufacturing automation and the enhancement and margin expansion of existing products. Led the Terumo Bay Area Innovation Laboratory (TBAIL) in Campbell, California in its search for novel application of emerging new technologies from Terumo. Recognized for leadership in Organizational Development and Talent Management processes.• Served as Executive Team member, facilitating strategic and financial growth of TMC business from ~$300M in revenue (2013) to over $1B in revenue projected for fiscal year 2023. • Grew TMC Elkton Maryland manufacturing facility from 20% utilized capacity, 34% margin operation to over $500M, 100% capacity, 67% margin operation.• Built high-performing engineering organization of over 150 engineering associates at TMC capable of contributing to and supporting achievement of the above significant revenue growth. • Executed internal new product/process development on several soon-to-be commercially released innovative new Entry Site Management, Lesion Access, and Interventional Solutions products.• Pivoted engineering organization to address challenges associated with EU/MDR compliance of several critical product lines gaining full EU MDR approvals in 2023.• Served as organizational strategist for machine automation, leading implementation of continuous stream of automated manufacturing processes (Capital Expenditure Program >$50M).

Established and executed Product Lifecycle Management (PLCM) organization focused on cardiovascular interventional system medical devices. Managed product lifecycle portfolio, strategic planning, new product development, process development and engineering, manufacturing engineering, and Project Management Office (PMO) execution. Implemented high-performing Talent management process for recruitment, acquisition, development, career progression, and retention of engineering and engineering management associates. • Implemented successful Engineering Co-Op Program with local Universities (Drexel University, Widener University) and engineering student projects (University of Delaware).• Implemented 3-year Engineering Development Rotational Program to recruit, train, develop and retain graduating engineering students into engineering organization.Oversaw significant manufacturing process transfers of existing products into Elkton Maryland facility from Terumo Japan and several M&A acquired product lines into TMC Elkton Maryland and Caguas Puerto Rico manufacturing sites.

Responsible for new product development, process development, and project management activities. Achievements included implementing state-of-the-art product development stage-gate and design control processes, deploying Design for Six Sigma (DFSS) tools, introducing Multi-Generational Portfolio Planning (MGPP), and establishing and staffing a formal PMO organization. Led a significant engineering organizational response to an FDA Warning Letter for a long-established medical device product and the resultant remediation of several additional product Design History Files (DHF) to ensure full compliance with global regulations.

Responsible for Neurosurgery Division's global R&D, Program Management, Medical Affairs and Regulatory Affairs functional departments and activities. - Executed strategic product development portfolio plans developed using Multi-Generational Portfolio Planning (MGPP) roadmap across Neurosurgery product platforms at multiple global R&D sites. - Led development and release of platform leading new products in Neurosurgery Division's core business areas to include regenerative dural repair and peripheral nerve repair, ICP Monitoring, Oxygen Monitoring, Tissue Ablation and Cranial Stabilization. - Implemented Design for Six Sigma (DFSS) into the new product development process while releasing platform leading new products in each of the Neurosurgery Division's core business areas. - Transformed the Clinical Affairs group into a Medical Affairs core competency, hiring Integra's first Chief Medical Officer (CMO). - Implementing a Multi-Generation Portfolio Planning (MGPP) process across all Integra Divisions allowing for improved identification and selection of key technologies and new product development projects to be advanced.

Successfully supported transition of new President into Neurosurgery Division. Led transformation of Neurosurgery Marketing function from qualitative driven organization to quantitative, data and metric driven organization resulting in better understanding of the customer, product category/product line performance, positioning in market, and defining strategic direction for Sales, Marketing and Product Development. Resumed responsibilities for project management and product development for Neurosurgery and Regenerative Tissue projects.

Driving growth of new orthopedic business unit, implemented portfolio-based Product Management of fixation and regenerative tissue and nerve guide products aligned with extremity reconstruction clinical disease states. Executed comprehensive product/market Gap Analysis by disease state to identify strengths and opportunities for business growth and translated them into active product development projects.

Implemented formal project management and built Project Management Office (PMO) organization to manage growing portfolio of Neurosurgical and Regenerative Tissue product development projects. Rebuilt product development and design control process to strengthen requirements definition and traceability throughout development process resulting in more customer relevant requirements being identified and developed for commercialization.

Responsible for Graco Children's Products' ideation, conceptualization, engineering development, and transfer to manufacturing activities releasing new products into the market within Graco's 12 product categories. - Led cross-functional activities of 90+ design, engineering and product development professionals within R&D, with an average annual operating budget of $12M and capital budget of $8-10M. - Made significant improvements to child car seat manufacturing and product performance. - Member of Graco Executive Management Advisory Council (MAC) and key participant in execution of monthly Operating Cycle requirements, (e.g., Product Development (lead), Manufacturing Operations, Quality/Productivity, Financial Performance Reviews), and ISO 9000 implementation efforts.

Led the expansion of strategic development, planning, business development and execution activities for offering Battelle-wide nuclear, biological, and chemical (NBC) terrorist threat infrastructure protection engineering services and solutions to federal, commercial, and international customers. - Successfully positioned Battelle as post 9/11 global leader in the protection of infrastructure assets from chemical or biological terrorist threats. - Developed strategic partnerships and relationships with key architectural and building/infrastructure firms for continued pursuit of new growth opportunities. - Increased infrastructure protection related revenue by over $20M by expanding capabilities, products, services.

Led the development and growth of the Battelle Edgewood Operations Engineering Products and Services Group to over 50 technical personnel generating $10M/year in revenue. - Guided development of the capability to protect occupants of buildings and other infrastructure assets from effects of a chemical or biological terrorist incident - Managed preparation of the winning contract proposal valued at over $11M and served as Battelle Team Program Manager for the Defense Advanced Research Projects Agency's (DARPA) prestigious Immune Building program. Subsequently won follow-on DARPA contracts valued at over $20M. - Led or served in a leadership role in the preparation, submission and award of 7 major technical and cost proposals valued at more the $150M.

Managed the execution of over 15 diverse technical projects ranging from project planning and technology assessments to product/system design, engineering and fabrication of military equipment and systems.

Led the execution of a $60M military development program providing integrated chemical warfare detection, warning, and collective protection equipment (CPE) capabilities to protect combat vehicle occupants on the battlefield.